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FDA 510(k)

INOMAX DS (DELIVERY SYSTEM), MODEL 10003

K-Number: K070867 · 2007-04-27

ApplicantIno Therapeutics, LLC
Decision Date2007-04-27
Product CodeMRN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INOMAX DS (DELIVERY SYSTEM), MODEL 10003 is the device name listed in this FDA 510(k) record. The listed applicant is Ino Therapeutics, LLC. It received FDA 510(k) clearance on 2007-04-27 under 510(k) number K070867. The device is classified under product code MRN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INOMAX DS (DELIVERY SYSTEM), MODEL 10003?

INOMAX DS (DELIVERY SYSTEM), MODEL 10003 is a medical device that received FDA 510(k) clearance on 2007-04-27. The listed applicant is Ino Therapeutics, LLC. The 510(k) number is K070867.

When did INOMAX DS (DELIVERY SYSTEM), MODEL 10003 receive FDA 510(k) clearance?

INOMAX DS (DELIVERY SYSTEM), MODEL 10003 received FDA 510(k) clearance on 2007-04-27, under 510(k) number K070867.

Who is the listed applicant for INOMAX DS (DELIVERY SYSTEM), MODEL 10003?

The FDA 510(k) record lists Ino Therapeutics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INOMAX DS (DELIVERY SYSTEM), MODEL 10003?

The FDA product code for INOMAX DS (DELIVERY SYSTEM), MODEL 10003 is MRN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Ino Therapeutics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K092545INOMAX DS (DELIVERY SYSTEM), MODEL 10003K090958INOMAX DS (DELIVERY SYSTEM)K081691INOMAX DS (DELIVERY SYSTEM)K071516INOMAX DS

Related Devices (Code: MRN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242374ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLCK242578EVOLVE Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLCK240410EVOLVE Nitric Oxide Delivery SystemMalinckrodt Manufacturing, LLCK233251NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.K222930Evolve Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLCK231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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